Prospective Sibling Oocyte Study of a New Method to Improve Embryo Development in IVF/ICSI Patients

January 7, 2026 updated by: Fecundis S.A.
Prospective, multi-centric, split-sample, sibling oocyte study evaluating the safety and efficacy of a new method to prepare sperm samples for IVF (in vitro fertilization) / ICSI (intracytoplasmic sperm injection) compared to standard procedures.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
    • Buenos Aires F.D.
      • Buenos Aires, Buenos Aires F.D., Argentina, 1058
        • In Vitro Buenos Aires
      • Buenos Aires, Buenos Aires F.D., Argentina, 1425
        • Pregna
      • Buenos Aires, Buenos Aires F.D., Argentina, 1428
        • WeFIV
    • Santa Fe Province
      • Rosario, Santa Fe Province, Argentina, 2282
        • Fertya

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 39 years (Adult)

Accepts Healthy Volunteers

No

Description

Female:

Inclusion Criteria:

  • With ovarian reserve of between 8 and 30 antral follicles counting both ovaries
  • Treatment planned for embryo transfer at the blastocyst stage

Exclusion Criteria:

  • Any diagnosed sexually transmitted infection (STI)
  • Diabetes or other metabolic disorders.
  • Recurrent pregnancy loss (defined as >2 clinical pregnancies without live birth).
  • Previous failures in two or more IVF cycles

Male:

Inclusion Criteria for IVF:

  • Age: 20-55 years
  • Fresh sample (not cryopreserved )
  • Sperm motility (TOTAL) ≥ 40% in spermogram
  • Normal sperm morphology (Kruger criteria) ≥ 4% in spermogram
  • Sperm count after swim up ≥ 5x10^6
  • Treatment planned for embryo transfer at the blastocyst stage

Inclusion Criteria for ICSI:

  • Age: 20-55 years
  • Fresh sample (not cryopreserved )
  • Sperm concentration ≥ 10x10^6 /ml in spermogram
  • Sperm motility (TOTAL) ≥ 20% in spermogram
  • Normal sperm morphology (Kruger criteria) ≥ 3% in spermogram
  • Treatment planned for embryo transfer at the blastocyst stage

Exclusion Criteria:

  • Any diagnosed sexually transmitted infection (STI)
  • Total failure of in vitro fertilization in previous cycles.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard Sperm Preparation
Sperm samples in the control group will undergo traditional processing in the lab prior to insemination.
Device: Standard Sperm Preparation
Standard sperm preparation
Experimental: HyperSperm
Sperm samples in the experimental group will undergo product-specific processing in the lab prior to insemination.
Device: HyperSperm
Multi-step sperm preparation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Development rate to blastocysts
Time Frame: Days 5-6 post insemination
Total blastocysts / total fertilized oocytes
Days 5-6 post insemination

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fertilization rate
Time Frame: Day 1 post insemination
Total fertilized oocytes (formation of two pronuclei) / total inseminated oocytes
Day 1 post insemination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fecundis S.A.

Investigators

  • Principal Investigator: Mariano Buffone, PhD, Fecundis Lab SL

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2023

Primary Completion (Actual)

December 18, 2025

Study Completion (Actual)

December 18, 2025

Study Registration Dates

First Submitted

December 6, 2022

First Submitted That Met QC Criteria

January 9, 2023

First Posted (Actual)

January 11, 2023

Study Record Updates

Last Update Posted (Estimated)

January 8, 2026

Last Update Submitted That Met QC Criteria

January 7, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Fecundis_2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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